1. Field of the Invention:
This invention relates generally to a decompression catheter, which might find application, for example, in small bowel enteroclysis.
2. Description of the Background
Oral methods are often advantageous in the medical examination of the small bowel, mainly due to the ease of performance. In this regard, enteroclysis is often considered a preferred oral method for examining the small bowel for irregularities, as it overcomes some of the interpretive and technical errors present in other oral methods.
Enteroclysis presents several practical and diagnostic advantages. Accordingly, this oral method has been used to successfully diagnose a wide variety of lesions. One advantage of enteroclysis over other oral methods of evaluating the small bowel is that it bypasses the regulation of the stomach and pylorus. Also, contrast material may be delivered at a preselected optimized rate. Further, direct infusion of the contrast material into the small bowel achieves simultaneous demonstration of all loops in the distended bowel. Thus, fold patterns are more accurately evaluated and surface abnormalities may show up more definitely. An additional advantage of enteroclysis is that the examination may be performed in a relatively short period of time.
It has been suggested that a catheter ideal for performing enteroclysis should incorporate certain features. It must be long enough to reach the infusion site and still allow the patient freedom to shift positions during the infusion. The diameter of the enteroclysis catheter should be minimized so that irritation to the nasopharyngeal or oropharyngeal tracts is minimized. Provision for preventing reflux of the infusion material into the stomach or decompressing refluxed contrast material in the stomach is advantageous. See, Maglinte DT, Small Bowel Radiography: How, When, and Why?, Radiology 1987; 163:297-305. The decompression catheter of the present invention supplies all the above features. Importantly, it incorporates an additional feature. Frequently, the infusion ports of enteroclysis catheters become obstructed with body tissue or other material, making further injection or withdrawal impossible. Thus, the additional feature is one which clears obstructed ports of the catheter so that injection or withdrawal may proceed.
Previously available small bowel decompression catheters are typically double-lumen catheters. These catheters take time to position in the proximal small bowel for effective decompression. In addition, the immediate performance of enteroclysis to ascertain the site and severity of the obstruction is not possible as these catheters are not adapted for contrast infusion into the bowel. When contrast media is injected, backflow into the stomach occurs because of the position of the holes in the end of the catheter.
The decompression catheter of the present invention, designed with a triple-lumen and incorporating a balloon, can be readily positioned directly in the proximal small bowel for effective decompression. It is adapted also for immediate enteroclysis for determination of the site and severity of obstruction or other diagnostic and intervention procedures. Further, a double sump is present which enables clearing of the infusion or withdrawal ports. Also, the distal portion may be tapered to minimize nasopharyngeal or oropharyngeal irritation during insertion.
Several drainage and/or irrigation devices are presently known. None, however, are well-suited for oral examination of the small bowel. Wilkinson, U.S. Pat. No. 4,364,394, discloses a combined sump drainage and irrigation device for evacuating liquid, blood or exudate from the peritoneal cavity for prolonged periods. The device incorporates a balloon to prevent dislocation of the device from the incision and a means to aid in equalizing pressure, inhibiting blockage of the suction passage. An infusion passage extends well beyond the distal end of the device's main body.
Onat, U.S. Pat. No. 4,114,625, teaches an oral-nasal gastric tube which includes three passages, one for inflating a balloon. The remaining two tubes open independently external of the device. One tube may be left open to the atmosphere to equalize pressure within the body.
Moss, U.S. Pat. No. 4,642,092, discloses a gastrointestinal aspirating device insertable through the body wall to prevent abdominal distension which frequently occurs when providing nutrition. Primary and smaller, secondary orifices are present in the aspirating lumen so that, should the primary orifices become blocked, the secondary orifices allow a pressure increase (a decrease in the level of suction) within the aspirating lumen.
A Ring-McLean sump drainage set, useful in draining abscesses, is also available. It is introducable by direct puncture from a trochar needle disposed therein. A secondary lumen allows pressure equalization at the distal tip of the catheter or flushing of the primary lumen via a syringe attachment.
None of the above devices disclose the principle of the present invention. That is, none disclose a catheter ideal for use in oral small bowel medical examinations.